Research and Develop the Process of Establishing Quality Control Samples for Determination of Formaldehyde Content in Vaccine

Abstract

Background/Purpose: Control sample is one of the important factors used to evaluate the
validity of an experiment in quality control. The study is conducted with the goal of
developing a process to establish a control sample for the test to determine the
formaldehyde content of vaccines in accordance with the conditions of the department and
to determine the standard used to evaluate the experimental value through the control
sample
Methods: Empirical description research in the laboratory
Results: In our research, we have built the procedure to set up a quality control sample for
determine the concentration of formaldehyde in vaccine as follow: Prepare 30 µg/ml
formaldehyde standard solution. Determine the acceptable concentration value (Mean
±10%) of the standard formaldehyde solution through experiments result. The control
sample (QC sample) is 30 µg/ml formaldehyde standard solution.
Conclusion: Successfully building a process to set up a control sample for the test to
determine the formaldehyde content of the vaccine in accordance with the conditions of
the department and determine the standard used to evaluate the test value through the
control sample